Virtual Reality for Seniors Under Spinal Anesthesia

(SILVR Trial)

Overseen By Nadia Godin

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Ciusss de L'Est de l'Île de Montréal

Disqualifiers: Epilepsy, Severe dizziness, Mental impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

55 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to evaluate the acceptability of intraoperative virtual reality in elderly patients under spinal anesthesia.

Research Team

Pascal Laferrière-Langlois

Principal Investigator

Ciusss de L'Est de l'Île de Montréal

Eligibility Criteria

This trial is for patients over 65 years old who are having elective surgery with spinal anesthesia. They must be able to give consent and use their hands. It's not for those with severe mental issues, epilepsy, recent eye or facial surgeries, or hearing/vision problems.

Inclusion Criteria

I am over 65 years old and have given my full consent.

I am scheduled for surgery that will use spinal anesthesia.

Exclusion Criteria

Severe mental impairment

I cannot use my hands.

I have a history of epilepsy, seizures, or severe dizziness.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Anxiety levels are assessed before surgery using the Amsterdam Preoperative Anxiety and Information Scale

2 hours

1 visit (in-person)

Intraoperative

Participants wear a virtual reality headset during surgery to evaluate tolerance and measure time worn

45 minutes

1 visit (in-person)

Postoperative

Patient satisfaction and ease of use of VR are assessed through semi-structured interviews

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for any adverse effects and overall satisfaction after the procedure

4 weeks

Treatment Details

Interventions

• Virtual Reality Headset

Trial Overview The study tests the acceptability of using a virtual reality headset during surgery in seniors under spinal anesthesia. The goal is to see if VR can improve the surgical experience for elderly patients.

Participant Groups

Group I: a group of 55 patients Experimental Treatment 1 Intervention

Virtual Reality Headset is already approved in United States for the following indications:

Approved in United States as Virtual Reality Headset for:

• Pain management
• Anxiety reduction

Who Is Running the Clinical Trial?

Ciusss de L'Est de l'Île de Montréal

Lead Sponsor

Trials

81

Recruited

6,400+